FDA.reportPublic FDA data

Calm Mood

Product NDC
51393-5006
11-digit product format
513935006
Labeler code
51393
Product ID
51393-5006_4b49d069-9ac0-4fb1-e063-6294a90af3b0
Type
HUMAN OTC DRUG
Nonproprietary name
Garlic, Avena Sativa Flowering Top, Angelica Archangelica Root, Arabica Coffee Bean, Holy Basil Leaf, Passiflora Edulis Flower, Scutellaria Lateriflora Whole, Verbena Hastata Top, and Macropiper Methysticum Root
Dosage form
SOLUTION/ DROPS
Route
SUBLINGUAL
Labeler
Forces of Nature
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-01-01
Substance
ANGELICA ARCHANGELICA ROOT; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; GARLIC; HOLY BASIL LEAF; MACROPIPER METHYSTICUM ROOT; PASSIFLORA EDULIS FLOWER; SCUTELLARIA LATERIFLORA WHOLE; VERBENA HASTATA TOP
Active strength
89; 30; 30; 89; 89; 30; 30; 12; 6 [hp_C]/100mL; [hp_C]/100mL; [hp_X]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL; [hp_C]/100mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Calm Mood
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GARLIC89 [hp_C]/100mL
AVENA SATIVA FLOWERING TOP30 [hp_C]/100mL
ANGELICA ARCHANGELICA ROOT30 [hp_X]/100mL
ARABICA COFFEE BEAN89 [hp_C]/100mL
HOLY BASIL LEAF89 [hp_C]/100mL
PASSIFLORA EDULIS FLOWER30 [hp_C]/100mL
SCUTELLARIA LATERIFLORA WHOLE30 [hp_C]/100mL
VERBENA HASTATA TOP12 [hp_C]/100mL
MACROPIPER METHYSTICUM ROOT6 [hp_C]/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1V998DC17Internal UNII lookup
MA9CQJ3F7FInternal UNII lookup
DTN01M69SNInternal UNII lookup
3SW678MX72Internal UNII lookup
SCJ765569PInternal UNII lookup
SY49TH8VUAInternal UNII lookup
7BP4DH5PDCInternal UNII lookup
CMJ753697IInternal UNII lookup
BOW48C81XPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0030a8b4-f70f-415d-bdb6-e2e70720b7a2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51393-5006-1Calm Mood10 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS103
51393-5006-1Calm Mood1 in 1 CARTONSOLUTION/ DROPS13
51393-5006-3Calm Mood1 in 1 CARTONSOLUTION/ DROPS13
51393-5006-3Calm Mood30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51393-5006CALM MOOD (GARLIC, AVENA SATIVA FLOWERING TOP, ANGELICA ARCHANGELICA ROOT, ARABICA COFFEE BEAN, HOLY BASIL LEAF, PASSIFLORA EDULIS FLOWER, SCUTELLARIA LATERIFLORA WHOLE, VERBENA HASTATA TOP, AND MACROPIPER METHYSTICUM ROOT) SOLUTION/ DROPS [FORCES OF NATURE]2Current NDC, Legacy NDC, 4 package rows20210713_0030a8b4-f70f-415d-bdb6-e2e70720b7a2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calm MoodGARLIC, AVENA SATIVA FLOWERING TOP, ANGELICA ARCHANGELICA ROOT, ARABICA COFFEE BEAN, HOLY BASIL LEAF, PASSIFLORA EDULIS FLOWER, SCUTELLARIA LATERIFLORA WHOLE, VERBENA HASTATA TOP, AND MACROPIPER METHYSTICUM ROOTForces of Nature0030a8b4-f70f-415d-bdb6-e2e70720b7a22026-02-25WarningsExact identifier
ndc (product): 51393-5006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51393-5006-1513935006011 BOTTLE, DISPENSING in 1 CARTON (51393-5006-1) / 10 mL in 1 BOTTLE, DISPENSING2021-01-010000-00-00NoNoCurrent
51393-5006-3513935006031 BOTTLE, DROPPER in 1 CARTON (51393-5006-3) / 30 mL in 1 BOTTLE, DROPPER2021-08-010000-00-00NoNoCurrent